HealthyNCT01945723
Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers
An observational study of Healthy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 10 healthy volunteers
Who may be able to join
- Healthy volunteers,
- Age: 20-60 years,
- Consent to perform endoscopic examination.
Who cannot join
- Antibiotics - a month prior to participation in the study,
- A chronic health condition.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Gastroentherology
Tel Aviv, 64239
Zamir Halpern, MD, 6974282, halpernza@tlvmc.gov.il
Zamir Halpern, MD
About this study
Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers.
Read the detailed description
During an endoscopic examination tissue samples will be taken from different regions of the gastrointestinal mucosa. The tissue samples will be used to characterize bacterial markers in the various intestinal segments.
- Conditions
- Healthy
- Keywords
- Endoscopy, Gastrointestinal tract, Bacterial markers, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial markers in different intestinal segments.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945723
- Sponsor's protocol ID
- TASMC-12-ZH-553-CTIL
- Status last verified
- Sep 2013
- First submitted
- 15 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01945723
- Acronym / sponsor ID
- TASMC-12-ZH-553-CTIL
- Conditions
- Healthy
- Keywords
- Endoscopy, Gastrointestinal tract, Bacterial markers, volunteers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers.
Detailed description
During an endoscopic examination tissue samples will be taken from different regions of the gastrointestinal mucosa. The tissue samples will be used to characterize bacterial markers in the various intestinal segments.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 10 healthy volunteers
Key inclusion criteria (3 listed)
- Healthy volunteers,
- Age: 20-60 years,
- Consent to perform endoscopic examination.
Key exclusion criteria (2 listed)
- Antibiotics - a month prior to participation in the study,
- A chronic health condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial markers in different intestinal segments.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial markers in different intestinal segments. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.